Probiotic Research for Mental Health in Adult Volunteers
Starting soon · Not applicable · Has a placebo group
Conditions studied: Healthy Adult Participants
In brief
This randomized, double-blind, placebo-controlled pilot study will evaluate the effects of four weeks of supplementation with a probiotic on mental health in healthy adults aged 18-30 years. Participants will be randomized to receive either probiotic or placebo and will complete study assessments at baseline and end of intervention, and will complete a range of behavioral, physiological, and questionnaire-based assessments before and after the intervention. The primary objective is to assess the effect on emotional reactivity measured in a virtual reality scenario at the end of the intervention. This exploratory study is intended to generate data to inform future clinical research.
Key facts
- Study ID
- NCT07751614
- Run by
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- People needed
- 60
- Starts
- 2026-09-01
- Expected to finish
- 2027-03-31
- Last updated by the study team
- 2026-08-07
Who can join
Age: 18 and older, up to 30. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 18-30 years of age
- Native-level Danish language skills
- No current psychiatric illness, confirmed with the Presence State Examination (PSE) and the Standardized Assessment of Personality (SAPAS)
- No previous history of severe psychiatric illness, including bipolar disorder, recurrent unipolar depression, psychosis spectrum disorders, personality disorders, autism spectrum disorders, or attention deficit (hyperactivity) disorder (ADHD/ADD), confirmed with PSE and SAPAS. Participants may still be included if they have a history of a single depressive episode, or have experienced symptoms of anxiety, stress, or burnout more than 6 months ago.
You may not qualify if…
- Recent use of probiotics (within the past 4 weeks)
- Use of antibiotics within the past 3 months
- Smoking, chewable tobacco, vaping, or use of other nicotine products
- Neurological disorders (including dementia)
- Use of psychotropic medication within the previous 6 months, including:
- Anxiolytics
- Antidepressants
- Antipsychotics
- Anticonvulsants
- Centrally acting corticosteroids
- Opioid pain relievers
- Hypnotics
- Prescribed sleep medications or herbal sleep aids (e.g., valerian)
- Dyslexia
- Severe physical illness, including:
- Cardiovascular disease
- Diabetes
- Gastrointestinal pathology (e.g., colon cancer, colitis, Crohn's disease)
- Gynecological pathology (e.g., endometriosis)
- Urologic pathology (e.g., prostate cancer)
- Severely immunocompromised status, including:
- HIV positive
- Being a transplant recipient
- Use of anti-rejection medication
- Use of steroids for more than 30 days
Full record on ClinicalTrials.gov
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